Endoscopic instruments

ABSTRACT

An endoscopic instrument used to form an artificial valve for treating gastroesophageal reflux disease (GERD).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application toYoshia Onuki et al, entitled “Endoscopic Instruments,” application No.60/281,016 filed Apr. 4, 2001.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to apparatuses for forming an artificialvalve to treat gastroesophageal reflux disease (GERD).

2. Description of the Related Art

The incidence of GERD has increased recently. The main symptoms of GERDare heartburn and mucosal breaks in the esophagus. Although it is abenign disease, GERD is accompanied by serious pain, and often requirestreatment. The main cause of GERD is decreased function of the loweresophageal sphincter (LES) at the bottom of the esophagus followed byreflux of acid into the esophagus. GERD is usually treated byadministration of acid secretion controlling agent such as proton-pumpinhibitor. Moderate GERD will improve and may be treated completely bymedication. If, however, the LES function is damaged seriously or ifanatomic problems such as hiatal hernias exist, treatment withmedication is less effective, and becomes costly over an extended periodof time.

Therefore, cases of serious GERD are often treated surgically. Effectivesurgical methods—including Nissen fundoplication or Toupet method—areknown and applied widely. With this method, the LES is wrapped by thestomach wall to improve its function. This method has been proven highlyeffective. Recently, laparoscopic surgery techniques were used with thismethod as a less invasive treatment. Because there are many patients,and GERD is a benign disease, these less invasive treatments are mostdesirable.

FIG. 39 depicts a tool for transoral treatment of GERD, disclosed inU.S. Pat. No. 5,887,594. This instrument (a) comprises a piercing device(e) having an elongate portion (b), a manipulation section (c) and ahook portion (d); and a securing device (i) having a connector (f), amanipulation section (g) and a securing mechanism (h). The piercingdevice (e) is inserted from the mouth to the stomach of a patient, andpulled up to the esophagus (k), with the hook portion (d) fixed at theupper stomach (j) thereby forming a fold of tissue (not shown).

Then, the securing device (i) is inserted into the esophagus (k) of thepatient, and the securing mechanism (h) fixes the fold consisting of theupper stomach (j) and the esophagus (k). When the fold is fixed, theintermediate portion is compressed to protrude inward to form a valve(not shown).

FIGS. 40 to 44 depict another transoral treatment method of GERD,disclosed in International Patent Publication WO99/22649. An instrument(n) has a rotatable fastener head (p), which is rotatable at the distalend of a flexible tube (o), and the rotatable fastener head (p) and aportion of the flexible tube (o) that can touch the rotatable fastenerhead (p) have a male fastener (g) and a female fastener (r),respectively. The flexible tube (o) has a rotatable grasper (s) at thedistal end, and an opening for an endoscope (t) to be insertedthroughout the flexible tube (o). First, the flexible tube (o) isinserted from the mouth to the stomach of the patient. The rotatablegrasper (s) is drawn into contact with a junction (v) between thestomach and the esophagus. The rotatable grasper (s) is operated to holdthe junction (v). Next, the flexible tube (o) is advanced downward tosuspend the junction (v). The rotatable fastener head (p) is operated topenetrate the junction (v) with the male fastener (q) to engage with thefemale fastener (r). Thus, the junction (v) and the middle part arecompressed to be protruded inward to form a protrusion (x).

In the composition disclosed in U.S. Pat. No. 5,887,594, the hookportion d of the piercing device (e) needs to be fixed to the stomachand pulled. The gastric wall, however, is thicker than the esophagus,and is divided into three regions: the inner mucous membrane; the middleproper muscularis; and the outer serous membrane. In particular, a spacebetween the mucous membrane and the proper muscularis has highmovability. To form a protrusion into a valve, tissue including theproper muscularis should be compressed and lifted up. The hook portion(d) only takes the mucous membrane and cannot include the propermuscularis below it. Thus, the valve formed in this application is notlarge and thick enough to prevent reflux satisfactorily.

In the apparatus disclosed in International Patent PublicationWO99/22649, the rotatable grasper (s) is integral to the flexible tube(o), which makes it difficult to touch the target tissue. The field ofview of the endoscope (t) is blocked by the rotatable fastener head (p),which makes difficult for the rotatable grasper (s) to hold and suspendthe junction (v) between the stomach and the esophagus.

Because the position between the rotatable grasper (s), the malefastener (q) and the female fastener (r) is fixed, the size of aprotrusion (x) is limited. It is desirable, however, to form aprotrusion of varying size depending on the degree of severity of GERD.The difficulty of passing food has already been reported as complicationof artificial cardia in Nissen fondoplication, and is likely to happenwith an excessively large protrusion (x). Even much smaller protrusion(x) is effective for the treatment of the moderate GERD. With thisapparatus, treatment is not flexible enough to allow a small protrusionto facilitate food flow in the case of moderate GERD. And further, themale fastener (q) is exposed outside the device, and may damage a bodylumen when it is introduced into it.

SUMMARY OF THE INVENTION

The first object of the present invention is to provide the apparatusfor forming a protrusion including the proper muscularis below themucous membrane to prevent gastroesophageal reflux effectively.

The second object of the present invention is to provide the apparatusfor forming a protrusion that is easy to operate and will treat in ashort time.

The third object of the present invention is to provide the apparatusfor holding and suspending the esophagogastric junction using a fixingdevice extending out of the distal end of an endoscope to improve theease of the operation for forming the protrusion.

The fourth object of the present invention is to provide the apparatusfor forming a protrusion of varying size by using a separate holdingdevice and a piercing means to achieve the flexible treatment method,which may be modified due to the degree of GERD severity.

The fifth object of the present invention is to provide the apparatusfor forming a protrusion safely without damaging a human body.

In accordance with the present invention, a tissue-piercing device, tobe used with an endoscope, which has two piercing members which have aneedle, also includes two slidable suture-holding means which areinserted in the each needle and are extended from or retracted into thedistal ends of the needles, and at least a holding-operation means foroperating the suture-holding means.

The tissue-piercing device may also include two slidable sutures whichare inserted in each needle.

It may also include a slidable suture-holding means which is inserted inone needle and is extended from or retracted into the distal end of theneedle, and a holding-operation means for operating the suture-holdingmeans, and a slidable suture inserted in the other needle. It ispossible for the suture-holding means to hold the suture.

The present invention is also directed to a treatment system comprisingfirst and second endoscopes to be inserted orally into a human body; atissue-piercing device according to the present invention being mountedto the first endoscope; a tissue-fixing device extending out of thedistal end of the second endoscope and fixed at a piercing point, and asuture which is folded in a U shape and inserted into a human body usingthe second endoscope.

A tissue-piercing device with two slidable sutures according to thepresent invention may be mounted to the first endoscope; a tissue-fixingdevice extending out of the distal end of the second endoscope and fixedat a piercing point, and a holding means for a suture which is insertedinto a human body using the second endoscope.

A tissue-piercing device with slidable suture-holding means according tothe present invention may be mounted to the first endoscope; and atissue-fixing device extending out of the distal end of the secondendoscope and fixed at a piercing point.

In the tissue-piercing device according to the present invention, thetwo needles may be parallel and apart from each other.

There may also be operation sections at the proximal ends of thepiercing members; a distal coupling member for connecting distal ends ofthe needles; and a proximal coupling member for connecting the operationsections of the piercing members.

The distal coupling member may be formed to be mounted to the distal endof the endoscope, and the proximal coupling member may be formed to bemounted to the operation section of the endoscope. The distal couplingmember may be a cap which may be made of transparent material.

In the tissue-piercing device according each piercing member may includea flexible outer sheath, a slidable flexible inner sheath which isinserted in the outer sheath and is extended from or retracted into thedistal end of the outer sheath, a slidable needle which is inserted inthe inner sheath and is extended from or retracted into the distal endof the inner sheath, a housing to be connected to the proximal end ofthe outer sheath, an inner sheath operation means connected to theproximal end of the inner sheath for moving back and forth the innersheath, and a needle operation means connected to the proximal end ofthe needle for moving back and forth the needle.

The tissue-piercing device may also include a switch means for switchingbetween a two-piercing member operation and a separate operation.

A switch means for switching between a two-needle/inner sheath operationand a separate operation may also be provided. When the switch meansselects a two-needle operation, the needle extension may be varied toallow piercing the tissue with one needle after another

The suture-holding means may be loop-shaped.

A driving member for rotating or moving back and forth thesuture-holding means may be provided at the proximal end of thesuture-holding means, and the central axis of the suture-holding meansmay be inclined against the longitudinal axis of the driving member.

The tissue-piercing device, to be used with an endoscope, may include adelivery means for delivering a knot of the suture into the target sitein the human body and tightening it.

The delivery means may comprise at least one hole.

The cap may have at least a side hole which performs as delivery meansfor delivering a knot of the suture formed outside the human body intoit.

The present invention is also directed to a tissue-fixing device, to beused with an endoscope, which comprises a delivery means for deliveringa knot of the suture into the target site in the human body andtightening it.

It is also directed to a knot pusher, to be used with an endoscope,comprising a pair of opening or closing jaws; and a hole made in eachjaw. The jaws may also serve as a means for fixing tissue.

The endoscope may be a flexible endoscope and embodiments of the presentinvention may be used to suture tissue in the human body. In particular,embodiments of the present invention may be used to form an artificialvalve for treating gastroesophageal reflux disease (GERD).

FIG. 1 shows a piercing device according to a first embodiment of thepresent invention;

FIG. 2 shows a main body of the piercing device according to the firstembodiment;

FIG. 3 shows an inner sheath according to the first embodiment;

FIG. 4 shows a needle according to the first embodiment;

FIG. 5 is a cross-sectional view of a proximal end of a grip of theoperation section of the piercing device according to the firstembodiment;

FIG. 6 is a cross-sectional view of the needle inserted into the innersheath according to the first embodiment;

FIG. 7 shows an inner sheaths-coupling member or needles-coupling memberaccording to the first embodiment;

FIG. 8 A shows a second endoscope having fixing-holding forceps insertedtherethrough and a suture inserted through an outer channel fixed to thesecond endoscope;

FIG. 9 shows a suture cartridge having a suture therein;

FIG. 10 shows the piercing device according to the first embodimentmounted to a first endoscope;

FIG. 11 shows grasping the cardia with fixing-holding forceps via thesecond endoscope and inserting the first endoscope to a piercingposition;

FIG. 12 shows piercing of the esophageal and gastric walls with thepiercing device of the first embodiment;

FIGS. 13–16 show insertion of a suture into the pierced tissue accordingto the first embodiment;

FIGS. 17–19 show fixing the suture and forming an artificial valveaccording to the first embodiment;

FIG. 20 shows the suture fixed in place;

FIG. 21 shows a piercing device according to a second embodiment of thepresent invention;

FIG. 22 shows a needle according to the second embodiment;

FIG. 23 shows a second endoscope having fixing-holding forceps insertedtherethrough and suture-holding forceps inserted through an outerchannel fixed to the second endoscope;

FIG. 24 shows grasping the cardia with fixing-holding forceps via thesecond endoscope, piercing the esophageal and gastric walls with thepiercing device according to the second embodiment via the firstendoscope and inserting two sutures, and capturing the two sutures witha holding section via the second endoscope;

FIGS. 25–27 show tying a knot in the sutures according to the secondembodiment of the present invention;

FIG. 28 shows a needle and suture-holding forceps according to a thirdembodiment of the present invention;

FIG. 29 shows a cross-sectional view of a needle grip according to thefirst embodiment;

FIG. 30 shows the suture-holding forceps of the third embodiment in useto capture a suture;

FIG. 31 shows a piercing device according to a fourth embodiment of thepresent invention;

FIGS. 32 and 33 show the piercing device of the fourth embodiment in useto form an artificial valve;

FIG. 34 shows a needles-coupling member according to a fifth embodimentof the present invention;

FIG. 35 shows a piercing device according to the fifth embodiment;

FIG. 36 shows esophageal and gastric walls being pierced by the piercingdevice of the fifth embodiment;

FIGS. 37( a) and 37(b) show alternate forms of fixing-holding forcepsaccording to a sixth embodiment of the present invention;

FIGS. 38( a) and 38(b) show sutures inserted in the

fixing-holding forceps shown in FIGS. 37( a) and 37(b), respectively,and FIG. 38( c) shows the fixing-holding forceps of the sixth embodimentused to push a knot against the esophageal wall;

FIG. 39 shows a tool for transoral treatment of GERD according to U.S.Pat. No. 5,887,594; and

FIGS. 40–44 show a tool for transoral treatment of GERD according, to WO99/22649.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

First Embodiment (FIGS. 1 to 20, 29)

Description of a Piercing Device and a Knot Pusher (FIGS. 1 to 7,10, 29)

A piercing device 1 comprises a main body 2, inner sheaths 3 a and 3 b,needles 4 a and 4 b, an inner sheaths-coupling member 5, and aneedles-coupling member 6.

The main body 2 comprises two outer sheaths 7 a and 7 b, caps 8connected at the distal ends of the sheaths 7 a and 7 b, and anoperation section 9 connected at the proximal end of the sheaths 7 a and7 b.

The cap 8 comprises an outer sheaths-connecting section 10, a distalcylindrical section 11, and a distal mounting section 12.

The distal cylindrical section 11 is made of a relatively hard material.Preferably, it is made of a transparent plastic material such aspolycarbonate lest it should obstruct the vision of a first endoscope27. Preferably, the inner diameter is about 5 to 15 mm, the wallthickness is about 1 mm. The length is about 3 to 10 mm, and a shortercylinder is better. Side holes 13 a and 13 b are positioned at theopposite sides, apart 180 degrees each other. The side holes 13 a and 13b are responsible for pushing a knot of a suture, and the piercingdevice 1 itself acts as a knot pusher. A suture (which will be describedlater) pass through the side holes 13 a and 13 b, which each have aninner diameter of preferably about 1 mm.

The distal mounting section 12 is cylindrical and is inserted detachablyto the distal end of the first endoscope 27. The first endoscope isflexible endoscope. The distal mounting section 12 is made of arelatively soft plastic material such as PVC or other thermoplasticelastomer. Its inner diameter depends on the size of the distal end ofthe endoscope to be used and is generally about 10 mm.

The outer sheaths-connecting section 10 has a ring section fixed overthe periphery of the distal cylindrical section 11, and connection legs14 a and 14 b which are extending longitudinally and axially, parallelwith each other. The connection legs 14 a and 14 b are preferablypositioned at opposite sides and 180 degrees apart from one another. Theconnection legs 14 a and 14 b are preferably apart by 10 to 20 mm,depending on the outer diameter of the distal cylindrical section 11.

The connection legs 14 a and 14 b have penetration holes and formopenings 15 a and 15 b at the distal end.

The outer sheaths 7 a and 7 b are hollow and flexible enough to followthe curvature of the first endoscope 27. For example, they are plastictubes made of fluoroplastics, polyethylene, polyamide, polyimide,polyurethane or other thermoplastic elastomer, or metal coils. They maybe metal coils covered by plastic tubes. They may be plastic tubes withmetal mesh to prevent kink. The inner diameter is about 1 to 2 mm, theouter diameter is about 1.5 to 3 mm, and the length is about 1 to 1.5 m.The distal ends of the outer sheaths 7 a and 7 b are fixed to theconnection legs 14 a and 14 b and are in parallel positions. Theopenings 15 a and 15 b are connected and communicated with the lumen ofthe outer sheaths 7 a and 7 b.

The operation section 9 comprises a base 16, grips 17 a and 17 b,sliders 18 a and 18 b, a proximal mounting section 20, and a channelport 21. The proximal ends of the outer sheaths 7 a and 7 b penetratethe base 16 and are connected to the distal ends of the grips 17 a and17 b.

The grips 17 a and 17 b are cylindrical, and have screws 24 a and 24 bon the periphery of the proximal ends with which slider locks 22 a and22 b are engaged. Between the screws 24 a and 24 b and the slider locks22 a and 22 b, there are elastic tubular fixing rings 23 a and 23 b madeof rubber such as silicon rubber or fluorine rubber, or thermoplasticelastomer. Sliders 18 a and 18 b are positioned slidably inside thefixing rings 23 a and 23 b. When the slider locks 22 a and 22 b aretightened, the fixing rings 23 a and 23 b are pressed longitudinally andexpanded radially to immobilize the sliders 18 a and 18 b.

The sliders 18 a and 18 b are cylindrical. They are comprised of sliderstoppers 25 a and 25 b at the proximal end for limiting a sliding areaagainst the grips 17 a and 17 b, slider port 19 a and 19 b, and narrowsections 26 a and 26 b for connecting the inner sheaths-coupling member5.

The proximal mounting section 20 is mounted at the distal end of thebase 16, and is fixed detachably to a forceps channel port 28 of thefirst endoscope 27.

The channel port 21 is mounted to the proximal end of the base 16, andis plugged detachably with a forceps valve 29. The channel port 21 isconnected through the lumen of the proximal mounting section 20 and thelumen in the base 16 to the forceps channel (not shown) of the firstendoscope 27.

The inner sheath 3 a or 3 b comprises an inner sheath port 30, an innersheath pipe 31, an O ring 32, and a sheath section 33. The inner sheath3 a or 3 b can be inserted via the slider port 19 into the outer sheath7.

When the inner sheath 3 is inserted to the outer sheath 7, the innersheath port 30 is connected detachably to the slider port 19. The innersheath port 30 has a lumen.

The inner sheath pipe 31 is connected to the sheath section 33 and theinner sheath port 30. The lumen of the inner sheath pipe 31 is alsocommunicated with the lumen of the sheath section 33 and the lumen ofthe inner sheath port 30.

The O ring 32 is held between the proximal end of the inner sheath pipe31 and the inner sheath port 30. It is made of elastic rubber such assilicon rubber or fluororubber, or thermoplastic elastomer. It isreceived in grooves 66 a and 66 b of a needle body 34 of the needle 4,which is described later, and stops movement of the needle body 34.

The sheath section 33 is hollow and flexible enough to follow thecurvature of the first endoscope 27. For example, it is a plastic tubemade of fluoroplastics, polyethylene, polyamide, polyimide, polyurethaneor other thermoplastic elastomer, or a metal coil. It may be a plastictube with metal mesh to prevent kink. The inner diameter is about 0.5 to1.5 mm, and the outer diameter is about 1 to 2.5 mm.

When the slider 18 slides against the grip 17, The sheath section 33slides in the outer sheath 7. The length of the inner sheath 3 isadjusted so that the distal end of the sheath section 33 is positionedproximal to the opening 15 when the slider 18 is pulled completely fromthe grip 17, and the distal end of the sheath section 33 is positioneddistally about 15 to 50 mm from the opening 15 of the cap 8 when theslider 18 is pushed sufficiently to touch the grip 17.

The needle 4 a or 4 b comprises a needle body 34, a needle grip 35, andsuture-holding forceps 38 inserted in them. The needle 4 a or 4 b can beinserted through the inner sheath port 30 into the inner sheath 3.

The needle body 34 is a metal pipe made of stainless steel or nitinol,which is resistant to pressure from the proximal end during piercing andflexible enough to follow the curvature of the first endoscope 27. Theinner diameter is about 0.5 mm and the outer diameter is about 1 mm.

To facilitate projection of the distal end of the needle body 34 out ofthe distal end of the inner sheath 3, the outer diameter of the needlebody 34 preferably approximates the inner diameter of the inner sheath3. The proximal end of the needle body 34 is connected a port body 36 ofthe needle grip 35. The needle body 34 has two grooves 66 a and 66 bnear the proximal end.

The needle body 34 slides in the inner sheath 3 by needle grip 35 movingback and forth against the inner sheath port 30. When the 0 ring 32 ofthe inner sheath 3 is engaged in the groove 66 a, the distal end of theneedle body 34 is positioned slightly proximal than the distal end ofthe sheath section 33, and when the 0 ring 32 is engaged in the groove66 b, the distal end of the needle body 34 extends out of the distal endof the sheath section 33. Preferably, the needle body 34 extends out ofthe distal end of the sheath section 33 by about 50 to 70 mm.Preferably, the distal ends of the needle bodies 34 a and 34 b should beapart by at least 10 mm when the needle bodies 34 a and 34 b extend outof the distal ends of the sheath sections 33 a and 33 b.

The needle grip 35 comprises a port body 36, a needle port 37, and aelastic cylindrical fixing ring 42 between them made of rubber such assilicon rubber or fluororubber, or thermoplastic elastomer.

The port body 36 and the needle port 37 have lumen and are connectedwith screws. An operation pipe 40 of the suture-holding forceps 38slides in the lumen. When the needle port 37 is tightened, the fixingring 42 is pressed longitudinally and expanded radially to fix theoperation pipe 40. The needle port 37 also has a narrow section 43 towhich the needles-coupling member 6 is connected.

The suture-holding forceps 38 is inserted in advance into the needlebody 34 and the needle grip 35 for sliding. The suture-holding forceps38 has a loop shaped holding section 41 at the distal end of theoperation pipe 40. The holding section 41 is a metal wire made ofstainless steel or nitinol, or plastic wire. The wire may be a singlewire or a stranded wire. It has the diameter, which allows retractingthe holding section 41 into the needle body 34. The holding section 41is adjusted to open by 10 to 20 mm when it extends out of the needlebody 34.

The holding section 41 can be of any loop shape. It may be like a basketforceps.

The operation pipe 40 extends from the proximal end of the holdingsection 41 to the proximal end of the needle port 37. The operation pipe40 is connected an operation knob 39 at the proximal end. The operationpipe 40 is a slim metal pipe for smooth rotation such as stainless steelor nitinol. The holding section 41 is rotated following the rotation ofthe operation knob 39.

The inner sheaths-coupling member 5 can be mounted to the narrowsections 26 a and 26 b of the sliders 18 a and 18 b detachably.

The inner sheaths-coupling member 5 is an elastic yet relatively hardplastic sheet. There are two slits 44 a and 44 b on one side, which areconnected to coupling holes 45 a and 45 b.

The width of the slits 44 a and 44 b are slightly narrower than theouter diameter of the narrow sections 26 a and 26 b of the sliders 18 aand 18 b. The inner diameter of the coupling holes 45 a and 45 b isnearly equal to the outer diameter of the narrow sections 26 a and 26 b.The each distance between the slits 44 a and 44 b, or coupling holes 45a and 45 b is equal to the distance between the narrow sections 26 a and26 b. When the slits 44 a and 44 b are pressed to the narrow sections 26a and 26 b, the slits 44 a and 44 b open to connect the coupling holes45 a and 45 b with the narrow sections 26 a and 26 b. To remove theinner sheaths-coupling member 5, the narrow sections 26 a and 26 b arepulled out of the slits 44 a and 44 b.

When the inner sheaths-coupling member 5 is mounted to the sliders 18 aand 18 b, both inner sheaths 3 a and 3 b can be moved back and forth atone time either by holding and moving one slider 18 or the innersheaths-coupling member 5. The inner sheaths 3 a and 3 b extend by thesame length out of the openings 15 a and 15 b.

To change the extension length of either inner sheath 3 a or 3 b, theinner sheaths-coupling member 5 is removed, and the sliders 18 a and 18b are operated separately.

The needles-coupling member 6 and the inner sheaths-coupling member 5are similarly composed. The needles-coupling member 6 can be mounted tothe narrow section 43 a and 43 b of the needle ports 37 a and 37 bdetachably. According to mounting and removing the needles-couplingmember 6, the needles 4 a and 4 b are operated at one time orseparately. When the separate operation is selected, the extensionlength of the needles 4 a and 4 b out of the distal end of the innersheath 3 a or 3 b may be varied.

Description of the Fixing-Holding Forceps and a Suture (FIGS. 8 and 9)

The fixing-holding forceps 46 comprises a distal section 47, an elongatesheath 48 fixed at the proximal end of the distal section 47 andinserted in a forceps channel 58 of a flexible second endoscope 57, andan operation section 49 fixed detachably at the proximal end of thesheath 48 for operating the distal section 47.

The distal end section 47 has a pair of jaws 59 a and 59 b. Theoperation section 49 has a slider handle 50. An operation cable (notshown) connects the jaws 59 a and 59 b with the slider handle 50. Thejaws 59 a and 59 b are opened or closed by moving the slider handle 50back and forth.

The proximal end of the sheath 48 with the operation section 49detached, is inserted from the distal opening of the forceps channel 58through a forceps channel port 60. The operation section 49 is thenmounted, and the fixing-holding forceps 46 is set on the secondendoscope 57.

A suture cartridge 52 is inserted movably in the lumen of an outerchannel 51 fixed on the outer periphery of the second endoscope 57.

The suture cartridge 52 comprises a hollow and flexible cartridge tube53, and a suture placed in the hollow lumen. The cartridge tube 53 ismade of plastic material such as fluoroplastics or polyethylene. Thecartridge tube 53 is preferably made of relatively transparent materialsuch as fluoroplastics so that the movement of the suture 54 isrecognized easily in an endoscopic image.

The suture 54 is bent at the proximal end of the cartridge tube 53 andis stored, movably, in a U-shape in the cartridge tube 53. The fold 56is exposed out of the proximal end of the cartridge tube 53. Suture ends55 a and 55 b are exposed out of the distal end of the cartridge tube53. At that point, the suture ends 55 a and 55 b are positioned so thatone is 5 to 10 mm in front of the other. The suture 54 is a generalsurgical suture made of, for example, nylon or silk. The suture 54 is0.2 to 0.5 mm thick, and preferably 0.3 to 0.4 mm thick. The suture ends55 a and 55 b are preferably colored differently for easy recognition: Apart from the suture end 55 a to the fold 56 is colored differently froma part from the suture end 55 b to the fold 56, and the two parts arewelded at the fold 56.

Mounting the Device to an Endoscope (FIGS. 8 and 10)

The piercing device 1 is mounted in the following procedure.

The proximal mounting section 20 is mounted to the forceps channel port28 of the first endoscope 27. The distal mounting section 12 of the cap8 is inserted to the distal end of the first endoscope 27 while theouter sheaths 7 a and 7 b are held lest they should be twisted. Theouter sheaths 7 a and 7 b are fixed at several points on the outerperiphery of the first endoscope 27 with surgical tape.

The inner sheaths 3 a and 3 b are inserted through the slider ports 19 aand 19 b to the outer sheaths 7 a and 7 b, and the inner sheath port 30a and 30 b are connected and fixed to the slider ports 19 a and 19 b.

With the suture-holding forceps 38 a and 38 b placed completely into theneedle bodies 34 a and 34 b, the needles 4 a and 4 b are insertedthrough the inner sheath ports 30 a and 30 b into the inner sheaths 3 aand 3 b. The groove 66 a of the needle bodies 34 a and 34 b should beengaged with the O ring 32 of the inner sheaths 3 a and 3 b. The needlebodies 34 a and 34 b are then positioned so as not to extend out of thedistal ends of the sheath sections 33 a and 33 b.

The sliders 18 a and 18 b are pulled proximally. The sheath sections 33a and 33 b are pulled in the outer sheaths 7 a and 7 b in advance sothat the distal ends of the sheath sections 33 a and 33 b are positionedmore proximally than the openings 15 a and 15 b.

The fixing-holding forceps 46 is mounted to the second endoscope 57 inadvance.

Holding and Pulling Down the Cardia (FIG. 11)

The sheath 48 of the fixing-holding forceps 46 is pulled proximally andretained in a position in which the distal section 47 preferably doesnot extend out of the distal end of the second endoscope 57. The secondendoscope 57 is inserted into the patient's body, advanced to thestomach, and inverted to look up at the cardia 61 for observation.

Next, the slider handle 50 is pushed out against the operation section49 distally to open the jaws 59 a and 59 b. The sheath 48 is sent towardthe distal end, and the jaws 59 a and 59 b are brought into contact withtissue of the greater curvature 62 of the cardia 61. The slider handle50 is then pulled proximally to close the jaws 59 a and 59 b and holdand fix the tissue 62.

The second endoscope 57 and the fixing-holding forceps 46 are pressedtogether into the patient's body and pulled down while the tissue 62 isheld and fixed between the jaws 59 a and 59 b.

When a valve to be formed is not so large, the cardia may not be heldand pulled down by the fixing-holding forceps 46.

Penetrating the Stomach and the Esophagus Using a Penetration Needle(FIGS. 11 and 12)

The first endoscope 27 is inserted parallel to the second endoscope 57.

The distal end of the first endoscope 27 is positioned at an upstreampoint 63 of the esophagogastric junction while they are observed. Thedistal end of the first endoscope 27 is inclined slightly toward thegreater curvature of the stomach. The sliders 18 a and 18 b are movedagainst the grips 17 a and 17 b to the distal end. The sheath sections33 a and 33 b are extended out of the openings 15 a and 15 b and pressedagainst the entering points 64 a and 64 b. Depending on the conditionand form of the body lumen, the inner sheaths-coupling member 5 iseither attached to the narrow sections 26 a and 26 b to press the sheathsections 33 a and 33 b at one time, or is removed to press the sheathsections 33 a and 33 b separately.

After the sheaths sections 33 a and 33 b are pressed, the slider locks22 a and 22 b are tightened to the grips 17 a and 17 b to fix thesliders 18 a and 18 b.

The needle grips 35 a and 35 b are pressed toward the distal end untilthe groove 66 b of the needle bodies 34 a and 34 b is engaged with the Oring 32, and the needle bodies 34 a and 34 b are extended out of thesheath sections 33 a and 33 b.

The needles-coupling member 6 is either attached to the narrow sections43 a and 43 b to press the needle bodies 34 a and 34 b at one time, oris removed to press the needle bodies 34 a and 34 b separately. Pressingthe needle bodies 34 a and 34 b at one time makes operation easy, butincreases penetration resistance of the needles and requires more forceto penetrate them into tissue. On the other hand, pressing the needlebodies 34 a and 34 b separately makes it easy to penetrate the tissue,but requires two rounds of penetration procedures.

When the needle bodies 34 a and 34 b are extended out of the sheathsections 33 a and 33 b, they pass through the entering points 64 a and64 b of the esophageal wall 67, the exiting points 65 a and 65 b of thestomach wall 68 near the cardia and enter the stomach.

The second endoscope 57 is used to check that the needle bodies 34 a and34 b enter the stomach.

Inserting a Suture to Tissue (FIGS. 13 to 16)

The suture cartridge 52 is inserted into the outer channel 51 andextended into the stomach while it is observed by the second endoscope57. The operation knob 39 a of the needle 4 a is pressed toward thedistal end and the holding section 41 a is extended out of the distalend of the needle body 34 a.

Either the suture cartridge 52 or the suture 54 is advanced or retreatedto insert the suture end 55 a into the holding section 41 a.

Because the holding section 41 a is synchronized and rotated with theoperation knob 39 a, it is easy to insert the suture end 55 a into theholding section 41 a.

The operation knob 39 a is pulled proximally to pull the holding section41 a into the needle body 34 a and hold the suture end 55 a.

The needle port 37 a of the needle grip 35 a is tightened to the portbody 36 a to lock the holding section 41 a and the suture end 55 a.

Similarly, the suture end 55 b is held by the holding section 41 b.

Since the holding sections 41 a and 41 b are loop shape, they canprevent that the suture 54 slips from the holding sections 41 a and 41b. As a result, it is easy to hold the suture 54 by the holding sections41 a and 41 b.

The needle grips 35 a and 35 b are then pulled back proximally and thedistal ends of the needle bodies 34 a and 34 b are pulled into thesheath sections 33 a and 33 b. The suture ends 55 a and 55 b penetratethe gastric wall 68 and the esophageal wall 67 and reach to the upstreampoint 63 of the esophagogastric junction.

The slide locks 22 a and 22 b are loosened, and the grips 18 a and 18 bare pulled back proximally to pull the distal ends of the sheathsections 33 a and 33 b in the outer sheaths 7 a and 7 b. The firstendoscope 27 is then removed from the patient's body. The suture 54 isdrawn out of the cartridge tube 53.

After the first endoscope 27 and the piercing device 1 are removed fromthe patient's body, the operation knobs 39 a and 39 b are pressed towardthe distal end to extend the holding sections 41 a and 41 b out of theouter sheaths 7 a and 7 b, and remove the suture ends 55 a and 55 b outof the holding sections 41 a and 41 b.

The suture ends 55 a and 55 b are pulled further to bring the fold 56into contact with the inner surface of the gastric wall 68.

The slider handle 50 of the fixing-holding forceps 46 is then movedtoward the distal end to open the jaws 59 a and 59 b and release thetissue 62. The second endoscope 57 is removed together with thefixing-holding forceps 46 and the cartridge tube 53.

Fixing the Suture and Forming an Artificial Valve (FIGS. 17 to 19)

The suture ends 55 a and 55 b are tied outside the patient's body toform a knot 69.

If the knot 69 is a so-called square knot as shown in FIG. 17, thesuture ends 55 a and 55 b are inserted into the side holes 13 a and 13 bat the distal cylindrical section 11 of the cap 8.

If the knot 69 is a so-called Roeder knot as shown in FIG. 18, only onesuture end 55 a is inserted into the side hole 13 a or 13 b.

The suture ends 55 a and 55 b are inserted in a way that they pass theinner to the outside of the distal cylindrical section 11.

The first endoscope 27 is advanced into the patient body while thesuture ends 55 a and 55 b are held and pulled.

The knot 69 is advanced by the distal cylindrical section 11 of the cap8 as the first endoscope 27 is inserted. The knot 69 can be observed bythe first endoscope 27.

When the knot reaches near the entering points 64 a and 64 b of theesophagus, the distal cylindrical section 11 is pressed against theesophageal wall 67, while the suture ends 55 a and 55 b are pulled tolock the knot 69.

The above procedure is repeated several times before it is checked thatthe knot 69 is tied firmly. Then the first endoscope 27 and the piercingdevice 1 are removed from the patient's body.

As a result, the gastric wall near the exiting points 65 a and 65 b isbrought close to the entering points 64 a and 64 b. The esophagogastricjunction 70 between the exiting points 65 a and 65 b and the enteringpoints 64 a and 64 b are contracted to form an inward projection 71.

Finally, excess sutures beyond the knot 69 are cut using endoscopicscissors, and are collected outside the body to finish the treatment.

The fixing-holding forceps 46 inserted in the second endoscope 57 allowpulling the tissue 62 while it is held and fixed. The jaws 59 a and 59 bare brought into contact with the tissue 62 under observation using thesecond endoscope 57, which simplifies operation and shortens its time.

Because the first endoscope 27 and the piercing device 1 which areoperated separately from the second endoscope 57 and the fixing-holdingforceps 46 are provided, the pulling amount of the cardia or theposition of the entering point 64 can be determined at an operator'sdiscretion to form a valve of any size, depending on the condition of aparticular patient.

The piercing device 1 incorporates two penetration needles in advance,so once the distal end of the first endoscope 27 approaches apenetration point of the esophageal wall 67, two needles can bepenetrated immediately. This also means easy operation and reduced time.

The piercing device 1 has the sheath sections 33 a and 33 b and thedistal end of them can be touched body tissue before shooting the needlebodies 34 a and 34 b. It makes it easy to locate the penetration pointand reliably penetrates toward the inside of the stomach through theesophagogastric junction 70. If a larger valve is not required, such avalve can be formed with no tissue 62 held and fixed by thefixing-holding forceps 46. It simplifies operation and shortens thetime.

The piercing device 1 has two penetration needles in parallel, so theentering points 64 a and 64 b and the exiting points 65 a and 65 b areset apart a desired distance. As a result, an area of the body tissue tobe contracted by the suture is not small but still large enough to forma valve of desired size.

The outer sheaths 7 a and 7 b which receive the needles 4 a and 4 b areattached to the cap 8 at a desired position. Only by attaching the cap 8to the distal end of the first endoscope 27, can the distal ends of theouter sheaths 7 a and 7 b be mounted easily to the distal end of thefirst endoscope 27 at a specified position. This shortens the timerequired for mounting to the endoscope.

The side holes 13 a and 13 b on the cap 8 are capable of holding andpushing the knot of the suture. It is not necessary to prepare a knotpusher for holding and pushing the knot, which decreases medical costsand eliminates the need for another tool.

The needles 4 a and 4 b can be housed in the inner sheaths 3 a and 3 band the outer sheaths 7 a and 7 b. The piercing device 1 is insertedinto a body lumen without damaging it.

Second Embodiment (FIGS. 21 to 27)

Only points which are different from those of the first embodiment aredescribed.

A piercing device 101 is the piercing device 1 with its needles 4 a and4 b replaced by needles 102 a and 102 b.

The needle 102 comprising a needle body 34, a needle grip 104 connectedproximal to the needle body 34, and a suture 103 inserted movably in theneedle body 34 and the needle grip 104. The needle grip 104 has a narrowsection 43 to which the needles-coupling member 6 is connected.

The lumen in the outer channel 51 fixed on the outer periphery of thesecond endoscope 57 has suture-holding forceps 105 which are insertedmovably.

The suture-holding forceps 105 comprise a flexible sheath 107, anoperation section 108 which is rotated against and connected proximal tothe flexible sheath 107, a handle 109 which slides against the operationsection (108), a driving member 110 which is connected at the distal endof the handle 109 and extended slidably in the sheath 107, and a holdingsection 106 connected at the distal end of the driving member 110. Theholding section 106 is extended out or withdrawn into the distal end ofthe sheath 107 by moving the handle 109 back and forth.

The holding section 106 can be of any loop shape, for example, snareforceps or basket forceps. The holding section 106 is a metal wire madeof stainless steel or nitinol, or a plastic wire. The wire can be asingle wire or strand wire. The wire is thick enough to pull the holdingsection 106 into the sheath 107. The holding section 106 is so sized asto open by 10 to 30 mm when it is extended out of the sheath 107.

The holding section 106 is bent and mounted to the driving member 110 sothat the central axis 111 of the loop forming the holding section 106inclines against the longitudinal direction of the driving member 110.

The driving member 110 is made of a metal wire that follows anyrotation. The holding section 106 rotates following the operationsection 108.

After the needle bodies 34 a and 34 b of the piercing device 101 mountedto the first endoscope 27 pierce the esophageal wall 67 and the gastricwall 68, the suture-holding forceps 105 are inserted into the outerchannel 51 fixed on the outer periphery of the second endoscope 57 tointroduce the distal end of the sheath 107 in the stomach underobservation using the second endoscope 57.

The handle 109 is pressed toward the distal end to extend the holdingsection 106 out of the sheath 107.

The sheath 107 is moved back and forth, or the operation section 108 isrotated, to rotate the holding section 106 and position it just belowthe needle bodies 34 a and 34 b. The sutures 103 a and 103 b inserted inthe needles 102 a and 102 b are pressed and inserted in the loop of theholding section 106.

The handle 109 is then pulled proximally to pull the holding section 106in the sheath 107 and hold and fix the suture ends 112 a and 112 b ofthe sutures 103 a and 103 b.

The suture-holding forceps 105 are removed from the outer channel 51while fixing the suture ends 112 a and 112 b.

The holding section 106 is opened again to remove the suture ends 112 aand 112 b. They are tied to form a knot 113, and the excess sutures arecut off. The sutures 103 a and 103 b exposing proximally beyond theneedle grip 104 a and 104 b of the needles 102 a and 102 b are pulled topull the knot 113 back into the patient's body. The knot 113 shouldtouch near the exiting points 65 a and 65 b of the stomach.

In addition to the effect of the first embodiment, because the holdingsection 106 of the suture-holding forceps 105 holds the suture ends 112a and 112 b at one time, suture-holding operations using thesuture-holding forceps in the body are halved, simplifying operation andreducing time.

Third Embodiment (FIGS. 28 and 30)

Only points which are different from those of the first embodiment aredescribed.

The suture-holding forceps 121 of the needle 120 have a holding section122 at the distal end of the operation pipe 40. The holding section 122is bent and mounted to the operation pipe 40 so that the central axis123 of the loop 124 forming the holding section 122 inclines against thelongitudinal axis of the operation pipe 40.

When the holding section 122 is rotated, the loop 124 forming theholding section 122 is moved in an area 125 larger than that of thefirst embodiment.

Because the loop 124 forming the holding section 122 moves in a largerarea, the suture-end is inserted into the loop 124 easily for improvedoperability and shortened time.

Fourth Embodiment (FIGS. 31 to 33)

Only points which are different from those of the first embodiment aredescribed.

A piercing device 140 is the piercing device 1 with one of the needles 4a and 4 b replaced by the needle 102 in the second embodiment, and theother replaced by a needle 141. The needle 102 is comprised same withthat of the second embodiment.

Suture-holding forceps 145 that extend from or retract into the needle141 have a holding section 142 at the distal end of the operation pipe40. The holding section 142 is bent and mounted to the operation pipe 40so that the central axis 143 of the loop 144 forming the holding section142 inclines against the longitudinal axis of the operation pipe 40.

The length L of the holding section 142 is longer than the distance Ibetween the two needle bodies 34 a and 34 b, and the suture end 112 ofthe suture 103 extending out of the needle 102 is inserted in a loop 144formed by the holding section 142.

The second endoscope 57 does not have the outer channel 51, and thefixing-holding forceps 46 are inserted in a forceps channel (not shown).

After the needle bodies 34 a and 34 b of the piercing device 140 whichare mounted to the first endoscope 27 pierce the esophageal wall 67 andthe gastric wall 68, the holding section 142 of the suture-holdingforceps 145 is extended out of the needle 34 b.

The operation knob 39 is rotated while it is observed by the secondendoscope 57 to rotate the holding section 142 until the longitudinalaxis of the needle body 34 a is positioned in the loop 144 of theholding section 142.

The suture 103 in the needle 102 is pressed out, and the suture end 112is inserted in the loop 144.

The operation knob 39 is pulled proximally to hold the suture end 112.

Next, with the suture 103 extending from the proximal end of the needlegrip 104 released, the needle grips 35 and 104 are pulled backproximally to retract the distal ends of the needle bodies 34 a and 34 binto the sheath sections 33 a and 33 b. Thus, the suture end 103penetrates the gastric wall 68 and the esophageal wall 67.

The suture is penetrated only with the piercing device 140 and anotherdevice such as suture-holding forceps is not necessary. Preparationbefore treatment is simplified and does not take a long time. Moreover,another tool is not necessary and the cost is reduced.

Because the second endoscope 57 does not require the outer channel 51,the second endoscope 57 is narrowed and inserted into a body lumeneasily.

Fifth Embodiment (FIGS. 34 to 36)

Only points different from those of the first embodiment are described.

A piercing device 150 is the piercing device 1 with the needles-couplingmember 6 replaced by a needles-coupling member 151.

The needles-coupling member 151 comprising a distal section 152, amiddle section 153 and a proximal section 154, and is shaped like acrank. The distal section 152 and the proximal section 154 arepositioned longitudinally apart each other. The distal section 152should be apart from the proximal section 154 by at least the thicknessof tissue to be penetrated, or at least 5 mm.

Coupling holes 45 a and 45 b of the needles-coupling member 151 aremounted via the slits 44 a and 44 b to the needle ports 37 a and 37 b ofthe needle grips 35 a and 35 b. Because the distal section 152 and theproximal section 154 are apart each other, the distal ends of the needlebodies 34 a and 34 b are longitudinally apart from each other. When theneedles-coupling member 151 is held and pressed toward the distal end,the needle bodies 34 a and 34 b are extended out of the inner sheaths 33a and 33 b with its distance between the two maintained.

When the piercing device 150 is used for penetrating the esophageal wall67 and the gastric wall 68, first needle body 34 a penetrates theesophageal wall 67 and the gastric wall 68; next needle body 34 bpenetrates them.

Because two needles never penetrates tissue at one time even if theneedles coupling-member 151 is pressed to operate the two needles,penetration resistance will not be increased, and penetration is easy.

Sixth Embodiment (FIGS. 37 and 38)

Only points that are different from those of the fixing-holding forceps46 in the first embodiment are described.

As shown in FIG. 37( a), fixing-holding forceps 160 have a pair of jaws162 a and 162 b at a distal end 161 for holding tissue. The jaws 162 aand 162 b have side holes 163 a and 163 b, and their distal end openings164 a and 164 b are positioned near the distal ends of the jaws 162 aand 162 b. The side holes 163 a and 163 b are large enough to pass asuture and are preferably at least 1 mm.

The fixing-holding forceps 160 can have a composition as shown in FIG.37( b). FIG. 37( b) is a view of the distal end with the jaws 162 a and162 b of the fixing-holding forceps 160 opened. The jaws 162 a and 162 bhave side holes 165 a and 165 b near the distal end. Slits 166 a and 166b are extended from the side holes 165 a and 165 b to the sides of thejaws 162 a and 162 b. The side holes 165 a and 165 b and the slits 166 aand 166 b are large enough to pass the suture, or preferably at least 1mm.

As shown in FIGS. 38( a) and (b), the suture 54 is inserted in the jaws162 a and 162 b and the side holes 163 a and 163 b or 165 a and 165 b.In the case shown in FIG. 37( b), the suture 54 is inserted through theslits 166 a and 166 b to the side holes 165 a and 165 b.

Then, while the suture ends 55 a and 55 b are held and pulled, thesecond endoscope 57 is advanced again into the body lumen.

As the second endoscope 57 is advanced, the knot 69 is also pushedforward by the distal ends of the jaws 162 a and 162 b while it isobserved under the second endoscope 57.

When the knot 69 reaches the esophageal wall 67, the jaws 162 a and 162b open, and the suture ends 55 a and 55 b are pulled to fix the knot 69.

Opening the jaws 162 a and 162 b applies more tensile strength to thesuture 54 proximal to the knot 69, thus fixing the knot 69 firmly. Thismeans that a formed valve is maintained reliably for a long time.

The fixing-holding forceps 160 hold a knot of the suture and do notrequire another knot pusher. Therefore, medical costs and preparationtime are reduced.

The outer diameter of the second endoscope 57 to which only one outerchannel 51 is mounted is smaller than that of the first endoscope 27 towhich two outer sheaths 7 a and 7 b of the piercing device are mounted.The fixing-holding forceps 160 attached to the second endoscope have ameans for delivering a knot of the suture to make it easy to insert anendoscope into the body.

The above compositions achieve the following performance.

The fixing means inserted in the second endoscope, which is differentfrom the first endoscope attached the piercing device, can pull downbody tissue while it is held and fixed reliably. The fixing means isbrought into contact with the body tissue under observation by theendoscope for easy operation and reduced time.

The first endoscope and the piercing device are provided separately fromthe second endoscope and the fixing means. Therefore, an operator cancontrol the pull of the cardia or the position of the needle enteringpoint and form a valve of any shape according to the condition of aparticular patient.

The piercing device integrates two penetration needles. When the distalend of the first endoscope attached the piercing device approaches apenetration point on the esophageal wall, two needles are ready to bepenetrated. Treatment is simplified with reduced operation time.

The piercing device makes the inner sheath touch the penetration pointbefore penetration. It makes it easy to locate the penetration point andreliably penetrates toward the inside of the stomach through theesophagogastric junction. If a large valve is not required, it is formedwithout holding or fixing body tissue using the fixing means. It furthersimplifies treatment and reduces operation time remarkably.

The piercing device has two penetration needles which are parallel and acertain distance apart from each other. Therefore, the two enteringpoints or two exiting points should also be a certain distance apart. Asa result, an area of body tissue to be contracted by a suture cannot betoo small. It is extended over a certain area and formed into a valve ofdesired size.

Two penetration needles are mounted at specified points on the cap atthe distal end of the piercing device. Only by connecting the cap to thedistal end of the first endoscope can the two penetration needles bemounted at the specified points against the distal end of the firstendoscope. It reduces time for mounting them on the endoscope.

The piercing device or the fixing means is equipped with a means forpushing a knot of the suture. It eliminates preparing another knotpusher. Medical costs and preparation time are reduced.

Also the piercing device is inserted into a body lumen without damagingit because the needles can be housed in the piercing device.

1. A tissue piercing device, to be used with an endoscope for suturingor ligating tissues in body cavities, said tissue-piercing devicecomprising: two piercing members each comprising a needle, said twoneedles being parallel and spaced apart at a constant interval; twoslidable suture holding means for holding a suture, said suture holdingmeans being respectively slidably inserted through the two needles to beextendable and retractable with respect to distal ends of the needles;and holding operation means for operating both said suture holdingmeans.
 2. A tissue piercing device according to claim 1, wherein each ofthe suture holding means comprises a loop; wherein a respective drivingmember is connected to a proximal end of each said suture holding means,the driving member being operable for rotating, advancing, andretracting the corresponding suture holding means; and wherein a centeraxis of each of the suture holding means is inclined with respect to alongitudinal axis of the corresponding driving member.
 3. A treatmentsystem comprising: a first endoscope; the tissue piercing deviceaccording to claim 1 mounted on a distal end of the first endoscope; asecond endoscope that is different from the first endoscope; a tissuefixing device provided at least at a distal end of the second endoscopefor fixing a site to be sutured; and a suture slidably inserted throughthe second endoscope.
 4. The treatment system according to claim 3,wherein the tissue fixing device comprises an engaging portion thatengages the suture, and wherein a knot formed in the suture is deliveredto a sutured site by advancing the second endoscope toward the suturedsite while the suture is engaged with the engaging portion.
 5. Thetissue piercing device according to claim 1, further comprising anengaging portion that engages the suture, wherein a knot formed in thesuture is delivered to a sutured site by advancing the tissue piercingdevice toward the sutured site while the suture is engaged with theengaging portion.
 6. A tissue piercing device to be used with anendoscope for suturing or ligating tissues in body cavities, said tissuepiercing device comprising: two piercing members each comprising aneedle, said two needles being parallel and spaced apart at a constantinterval; two slidable suture holding portions respectively slidablyinserted through the two needles to be extendable and retractable withrespect to distal ends of the needles; and a holding operation portionfor operating the suture holding portions; wherein each of the sutureholding portions comprises a suture holding section adapted to extendfrom the distal end of the respective needle to capture a suture and toretract into the distal end of the needle to pull the suture into theneedle.
 7. A tissue piercing device according to claim 6, wherein eachof the suture holding portions comprises a loop; wherein a respectivedriving member is connected to a proximal end of each of the sutureholding portions, the driving member being operable for rotating,advancing, and retracting the suture holding portion; and wherein acenter axis of each of the suture holding portions is inclined withrespect to a longitudinal axis of the respective driving member.
 8. Atreatment system, to be used with an endoscope for suturing or ligatingtissues in body cavities, said treatment system comprising: first andsecond endoscopes for peroral insertion through body cavities; a tissuepiercing device mountable to the first endoscope, said tissue piercingdevice having two piercing members each comprising a needle, and saidtwo needles being parallel and spaced apart at a constant interval; atissue fixing device projecting from a distal end of the secondendoscope for fixing a site to be pierced; a suture holding portionslidably inserted through at least one of the needles of the tissuepiercing device; and a suture being slidably inserted through one of:one of the needles of the tissue piercing device, and the secondendoscope.
 9. A treatment system according to claim 8, wherein each saidsuture holding portion comprises a loop; wherein a respective drivingmember is connected to a proximal end of each said suture holdingportion, the driving member being operable for rotating, advancing, andretracting the suture holding portion; and wherein a center axis of eachsaid suture holding portion is inclined with respect to a longitudinalaxis of the respective driving member.